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NCT00322387 · OUTCOME

Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients · Source last updated 2014-03-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
transplants
Interval / dispersion
Not reported
Time frame
2 months

What was measured

Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.

Analysis population: Intent to treat population. Six participants with MM had 2 transplants.

Groups in this outcome

Non-Hodgkin's Lymphoma (NHL): Plerixafor PM

Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.

Non-Hodgkin's Lymphoma (NHL): Plerixafor AM

Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo

Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Multiple Myeloma (MM): Plerixafor PM

Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.

Multiple Myeloma (MM): Plerixafor AM

Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM

Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

Multiple Myeloma (MM): Plerixafor After Chemo

Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM7
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM6
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo1
Multiple Myeloma (MM): Plerixafor PM12
Multiple Myeloma (MM): Plerixafor AM9
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM1
Multiple Myeloma (MM): Plerixafor After Chemo4

Analysis denominator · transplants

GroupSource count
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM7
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM6
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo1
Multiple Myeloma (MM): Plerixafor PM14
Multiple Myeloma (MM): Plerixafor AM12
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM2
Multiple Myeloma (MM): Plerixafor After Chemo4

Reported measurements

≤ Day 12
Values in transplants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM6Not reportedNot reportedNot reportedNot reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM4Not reportedNot reportedNot reportedNot reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor PM14Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor AM9Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM1Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor After Chemo0Not reportedNot reportedNot reportedNot reported
Day 13 to Day 21
Values in transplants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM1Not reportedNot reportedNot reportedNot reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM2Not reportedNot reportedNot reportedNot reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo1Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor PM0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor AM3Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM1Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor After Chemo4Not reportedNot reportedNot reportedNot reported
≥ Day 22
Values in transplants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM0Not reportedNot reportedNot reportedNot reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM0Not reportedNot reportedNot reportedNot reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor PM0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor AM0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM): Plerixafor After Chemo0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        14
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    ≤ Day 12
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        4
    title
    Day 13 to Day 21
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    ≥ Day 22
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      4
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      14
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      2
    7. group Id
      OG006
      value
      4
    units
    transplants
description
Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
groups
  1. description
    Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
    id
    OG000
    title
    Non-Hodgkin's Lymphoma (NHL): Plerixafor PM
  2. description
    Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
    id
    OG001
    title
    Non-Hodgkin's Lymphoma (NHL): Plerixafor AM
  3. description
    Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
    id
    OG002
    title
    Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo
  4. description
    Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
    id
    OG003
    title
    Multiple Myeloma (MM): Plerixafor PM
  5. description
    Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
    id
    OG004
    title
    Multiple Myeloma (MM): Plerixafor AM
  6. description
    Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
    id
    OG005
    title
    Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM
  7. description
    Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
    id
    OG006
    title
    Multiple Myeloma (MM): Plerixafor After Chemo
param Type
NUMBER
population Description
Intent to treat population. Six participants with MM had 2 transplants.
reporting Status
POSTED
time Frame
2 months
title
Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
type
SECONDARY
type Units Analyzed
transplants
unit Of Measure
transplants

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Preserved source evidence · Not medical advice